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A study to find out whether antibiotic soaked autografts provide any additional benefit at reducing postoperative infection after knee ligament surgery.

Effect of using vancomycin pre-soaked autograft in functional outcome and postoperative infection rate after primary ACL reconstruction - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060824
Enrollment
50
Registered
2023-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S835- Sprain of cruciate ligament of knee

Interventions

Intervention1: Drug-Vancomycin: Dose & Duration-Once the autograft had been harvested, it will be thoroughly soaked into the 5 mg per mL vancomycin solution for 10 min. Freqency-Single time intraopera

Sponsors

Pt B D Sharma PGIMS ROHTAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients with age 18 to 45 years undergoing arthroscopic primary ACL reconstruction. 2. Patients with isolated Anterior Cruciate Ligament injury.

Exclusion criteria

Exclusion criteria: 1.Patients who do not give consent. 2.Patients less than 18 years of age. 3.Patients having any other pathological disease like osteoarthritis. 4.Patients with any psychiatric disorder. 5.Revision ACL surgery. 6.Had any history of diabetes or immunosuppression. 7.Had a known allergy to penicillin,cephalosporin,vancomycin,glycopeptide, iodine.

Design outcomes

Primary

MeasureTime frame
Post operative infection within 3 months after ACL reconstruction if any. Functional Outcome will be measured by Lysholm score and IKDC subjective score.Timepoint: All cases will folllow up on post op Day3, Day14, then at 3 wks and at 3 months. Functional Outcome will be measured at 6 month follow up by.

Secondary

MeasureTime frame
To evaluate postoperative complication following ACL reconstructionTimepoint: at 6 month postoperative

Countries

India

Contacts

Public ContactDr Sabuj Baran Singha

Pt. B D Sharma Institute Of Medical Sciences ,PGIMS Rohtak

doctorsabuj7@gmail.com8116423661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026